Trial Outcomes & Findings for Application of a Novel Allergen-Specific Immune Signature Directed Approach to Dietary Elimination Therapy in Patients With Eosinophilic Esophagitis (IDiET) (NCT NCT02722148)

Results Overview

The primary outcome will be histologic response, defined as a post-treatment esophageal eosinophil count of \<15 eos/hpf.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

24 participants

Primary outcome timeframe

6 Weeks

Results posted on

2019-04-02

Participant Flow

Participant milestones

Participant milestones
Measure	Enrolled Patients All enrolled subjects will receive a novel allergen-specific immune signature directed approach to dietary elimination therapy Novel Allergen-Specific Immune Signature Directed Approach to Dietary Elimination Therapy: A novel assay developed by the investigator to diagnose food allergens. Results from the assay are used to guide food elimination therapy for the treatment of Eosinophilic Esophagitis (EoE).
Overall Study STARTED	24
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Enrolled Patients All enrolled subjects will receive a novel allergen-specific immune signature directed approach to dietary elimination therapy Novel Allergen-Specific Immune Signature Directed Approach to Dietary Elimination Therapy: A novel assay developed by the investigator to diagnose food allergens. Results from the assay are used to guide food elimination therapy for the treatment of Eosinophilic Esophagitis (EoE).
Overall Study Lost to Follow-up	2
Overall Study Non compliant with treatment regimen	3

Baseline Characteristics

Application of a Novel Allergen-Specific Immune Signature Directed Approach to Dietary Elimination Therapy in Patients With Eosinophilic Esophagitis (IDiET)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Enrolled Patients n=22 Participants All enrolled subjects will receive a novel allergen-specific immune signature directed approach to dietary elimination therapy Novel Allergen-Specific Immune Signature Directed Approach to Dietary Elimination Therapy: A novel assay developed by the investigator to diagnose food allergens. Results from the assay are used to guide food elimination therapy for the treatment of Eosinophilic Esophagitis (EoE).
Age, Continuous	43.9 years STANDARD_DEVIATION 15.6 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 Weeks

Population: Data reported only for compliant participants

The primary outcome will be histologic response, defined as a post-treatment esophageal eosinophil count of \<15 eos/hpf.

Outcome measures

Outcome measures
Measure	Enrolled Patients n=19 Participants All enrolled subjects will receive a novel allergen-specific immune signature directed approach to dietary elimination therapy Novel Allergen-Specific Immune Signature Directed Approach to Dietary Elimination Therapy: A novel assay developed by the investigator to diagnose food allergens. Results from the assay are used to guide food elimination therapy for the treatment of Eosinophilic Esophagitis (EoE).
Percentage of Histologic Responders	21 percentage of participants

SECONDARY outcome

Timeframe: 6 Weeks

Eosinophil count per High Power Field

Outcome measures

Outcome measures
Measure	Enrolled Patients n=19 Participants All enrolled subjects will receive a novel allergen-specific immune signature directed approach to dietary elimination therapy Novel Allergen-Specific Immune Signature Directed Approach to Dietary Elimination Therapy: A novel assay developed by the investigator to diagnose food allergens. Results from the assay are used to guide food elimination therapy for the treatment of Eosinophilic Esophagitis (EoE).
Median Peak Esophageal Eosinophil Count	35 eosinophils per high power field Interval 20.0 to 63.0

SECONDARY outcome

Timeframe: 6 Weeks

Post treatment endoscopic appearance, as measured by a validated endoscopy score - the EoE Endoscopic Reference Score (EREFS). This score measures endoscopic severity with a set of five endoscopic findings (exudates, rings, edema, furrows, and strictures), and ranges from 0-9, with higher scores indicating higher endoscopic severity.

Outcome measures

Outcome measures
Measure	Enrolled Patients n=19 Participants All enrolled subjects will receive a novel allergen-specific immune signature directed approach to dietary elimination therapy Novel Allergen-Specific Immune Signature Directed Approach to Dietary Elimination Therapy: A novel assay developed by the investigator to diagnose food allergens. Results from the assay are used to guide food elimination therapy for the treatment of Eosinophilic Esophagitis (EoE).
Endoscopy Score	3.0 units on a scale Standard Deviation 1.9

SECONDARY outcome

Timeframe: 6 Weeks

Post treatment symptoms, as measured by a validated dysphagia symptom score, the EoE Symptom Activity Index (EEsAI). This score ranges from 0-100, with higher scores indicating more severe symptoms. A score of \< 20 indicates clinical remission.

Outcome measures

Outcome measures
Measure	Enrolled Patients n=19 Participants All enrolled subjects will receive a novel allergen-specific immune signature directed approach to dietary elimination therapy Novel Allergen-Specific Immune Signature Directed Approach to Dietary Elimination Therapy: A novel assay developed by the investigator to diagnose food allergens. Results from the assay are used to guide food elimination therapy for the treatment of Eosinophilic Esophagitis (EoE).
Dysphagia Symptom Score	25.0 score on a scale Standard Deviation 23.1

Adverse Events

Enrolled Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Evan S. Dellon

University of North Carolina at Chapel Hill

Phone: (919) 966-2513

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place